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XactTS Steerable Transseptal Catheter SS-001

by Keystone Heart, Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850020653003 UDI-DI Date24 Mar 2021ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
XactTS Steerable Transseptal Catheter
Generic Name
Vascular guide-catheter, single-use
Model / Ref / Catalog
SS-001, FG00006
Primary DI / UDI-DI
00850020653003
510(k) Number
FDA Product Code
DYB
GMDN Term
Vascular guide-catheter, single-use
Device Class
Class II
Regulation Number
870.1340
GUDID distribution status
In Commercial Distribution
Size
Catheter Gauge — 8.5 French

Related devices

Category: Vascular guide-catheter, single-use

Other devices from Keystone Heart, Ltd.

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No